MAUDE Adverse Event Report: ARTHREX INC. UNIVERS REVERS GLENOSPHERE 42 +4 LAT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number AR-9504L-04

Device Problem Disassembly (1168)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested/is expected for evaluation but has not yet been received.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

It was reported that the patient underwent a univers reverse tsa on (b)(6) 2018.The same surgeon performed a revision univers reverse tsa procedure on (b)(6) 2018 due to the glenosphere disassociating from the baseplate at the morse taper.Follow-up investigation: an l/42 humeral insert (ar-9503l-03 / lot: 170016710, line 226431) and an 42+4 univers revers glenosphere (ar-9504l-04 / lot: 17009813, line 226918) were implanted during the original procedure on (b)(6) 2018 and explanted during the revision surgery on (b)(6) 2018.X-rays were taken however, not yet provided.The explanted hardware was replaced with the following: ar-9404l-04, lot: 170009813.Ar-9503l-06, lot: 170005010.

• Brand Name: UNIVERS REVERS GLENOSPHERE 42 +4 LAT
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7398758
• MDR Text Key: 104417979
• Report Number: 1220246-2018-00117
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867061347
• UDI-Public: 00888867061347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: AR-9504L-04
• Device Lot Number: 170009813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other